Rifaximin to Prevent Recurrent HCV-Related Fibrosis After Liver Transplant

NCT01603108 | Unknown Phase 2

• 1 other identifier: AAAI4155
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.

Conditions

Hepatitis C

Keywords

Liver Transplant Recipient; Recurrent Fibrosis

Outcome Measures

Primary Outcomes (1)

• Significant recurrence of Hepatitis C

  Significant recurrence of hepatitis C at one year post-LT defined as at least stage 2 fibrosis, fibrosing cholestatic hepatitis or death/graft failure due to HCV.

  One year post liver transplant

Secondary Outcomes (3)

• Measurement of Serum LPS

  3 months and 12 months post liver transplant

• Measurement of mRNA markers of the fibrosis cascade

  3 months and 12 months post liver transplant

• Number of adverse events (severe and non-serious)

  Up to 30 days post study participation

Study Arms (2)

Rifaximin Arm

EXPERIMENTAL

Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.

Drug: Rifaximin

Placebo Control Arm

PLACEBO COMPARATOR

Rifaximin placebo will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin placebo will be taken twice daily for 90 days (+/- 10 days) post-LT.

Drug: Placebo

Interventions

Rifaximin DRUG

Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.

Also known as: Xifaxin

Rifaximin Arm

Placebo DRUG

Rifaximin placebo will be initiated post LT, once the subject is able to tolerate oral medications/diet. Rifaximin placebo dosed at 550 mg twice daily for 90 days (+/10 days) post LT.

Also known as: No other name

Placebo Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent before any study assessment is performed
• Age ≥ 18 years
• Willing and able to sign informed consent
• Chronic HCV infection with viremia
• Listed for liver transplantation
• Demonstrate ability to take oral medications prior to randomization (post LT)

You may not qualify if:

• Age \< 18 years old
• Unwilling/able to sign informed consent
• Cleared HCV infection (and therefore not at risk for recurrent HCV)
• Human immunodeficiency virus (HIV) co-infection
• Hepatitis B (HBV) co-infection
• Participation in another interventional clinical trial
• Females of childbearing (reproductive) potential must have a negative serum pregnancy test at Screening and agree to use an acceptable method of contraception throughout their participation in the study
• Subjects with history of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin
• Subjects with history of tuberculosis infection or has received treatment for tuberculosis infection. If subject has previous positive test for tuberculosis antigen then they must have current negative chest x-ray to be eligible
• Subject has diarrhea and positive Clostridium difficile (C. difficile) toxin via stool examination during Screening period. NOTE: Stool examination for C. difficile toxin will be performed on subjects who have diarrhea during the screening period. Results of stool tests should be confirmed as negative prior to randomization

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center - NYPH

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Elizabeth Verna, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 22, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

US (1)